Archive | Regulatory

FDA Approves Keytruda for Melanoma Patients After Tumor Resection

Source: Immuno-Oncology News, March 2019 The U.S. Food and Drug Administration has approved the use of Keytruda(pembrolizumab) as a treatment for melanoma patients with stage 3 disease — cancer cells have spread to the lymph nodes but not to distant organs — who have undergone complete resection of a tumor. The approval is based on data […]

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NICE recommends new treatment for unresectable or metastatic melanoma with a BRAF V600 mutation

Source: Pharma Field, February 2019 NICE recommends new treatment for adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation. Pierre Fabre welcomes the National Institute for Health and Care Excellence (NICE) decision to fund BRAFTOVI® (encorafenib) in combination with MEKTOVI® (binimetinib) for the treatment of adult patients with unresectable or metastatic melanoma […]

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Chinese authorities approve Sino Pharma’s lenalidomide for multiple melanoma

Source: Pharmaceutical Technology, February 2019 Chinese Sino Pharmaceutical has announced that China’s National Medical Products Administration has approved its subsidiary Chia-Tai Tianqing Pharmaceutical’s anti-tumour drug lenalidomide for multiple melanoma. The approval is due to the convenience of oral administration, proven efficacy and good safety profile, and allows the drug to be taken in conjunction with […]

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NICE clears Pierre Fabre’s targeted melanoma combo to take on Novartis, Roche drugs

Source: Fierce Pharma, February 2019 Thanks to new guidance from England’s drug cost watchdog, Novartis and Roche will be getting some fresh targeted melanoma competition from French pharma lab Pierre Fabre. In guidance published Friday, England’s National Institute for Health and Care Excellence signed off on Pierre Fabre’s combo of Braftovi and Mektovi to treat adult patients with unresectable or metastatic BRAF […]

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Posted in Melanoma News, Regulatory, Publications